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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Port & Catheter, Implanted, Subcutaneous, Intravascular
510(k) Number K073423
FOIA Releasable 510(k) K073423
Device Name MRI POWERPORT IMPLANTED PORT WITH 9.6 FR SILICONE CATHETER
Applicant
C.R. BARD, INC.
605 N 5600 W
SALT LAKE CITY,  UT  84116
Applicant Contact SUSAN D SCOTT
Correspondent
C.R. BARD, INC.
605 N 5600 W
SALT LAKE CITY,  UT  84116
Correspondent Contact SUSAN D SCOTT
Regulation Number880.5965
Classification Product Code
LJT  
Date Received12/05/2007
Decision Date 12/19/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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